High-pressure balloons and methods for making them

Abstract

Flexible high-pressure angioplasty balloons are disclosed herein which utilize an inflatable balloon positioned upon the catheter and a supporting structure secured over or along the catheter at a first location proximal to the balloon and at a second location distal to the balloon. Inflation of the balloon reconfigures the supporting structure to urge the first location and the second location towards one another thereby inhibiting longitudinal elongation of the balloon relative to the catheter. The supporting structure may surround, support, or otherwise extend over the entire length of the balloon and allows for the balloon to retain increased flexibility which enables the balloon to bend or curve even at relatively high inflation pressures.

1 . A device for performing procedure within a patient's body, comprising:
 a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a longitudinal axis extending therebetween;   a non-compliant balloon carried on the distal end comprising a central region and end regions transitioning from the central region to attachment locations on the distal end, the balloon expandable from a contracted condition to an expanded condition; and   a supporting structure comprising a plurality of substantially inelastic fibers formed as a braid extending helically around an outer surface of the balloon and comprising opposite ends fixedly attached over the respective attachment locations such that intermediate regions the fibers are movable relative to the central region of the balloon;   wherein the fibers comprise a first set of fibers comprising polyethylene and a second set of fibers comprising polyamide.   
     
     
         2 . The device of  claim 1 , wherein the first set of fibers is formed entirely from polyethylene. 
     
     
         3 . The device of  claim 2 , wherein the second set of fibers is formed entirely from polyamide. 
     
     
         4 . The device of  claim 1 , wherein the first set of fibers comprises polyethylene naphthalate (“PEN”) and the second set of fibers comprises Nylon 6. 
     
     
         5 . The device of  claim 1 , wherein the opposite ends of the fibers are welded to the attachment locations with the second set of fibers providing flux material to embed the opposite ends into the balloon material at the attachment locations. 
     
     
         6 . The device of  claim 1 , wherein the attachment locations comprise relatively narrow necks on the end regions and wherein the opposite ends of the fibers are welded to the necks. 
     
     
         7 . The device of  claim 6 , wherein the opposite ends of the second set of fibers are partially melted to embed the opposite ends of the fibers to the respective necks. 
     
     
         8 . The device of  claim 1 , wherein the first and second sets of fibers are distributed substantially uniformly around a circumference of the supporting structure. 
     
     
         9 . A device for performing procedure within a patient's body, comprising:
 a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a longitudinal axis extending therebetween;   a non-compliant balloon formed from nylon or PEBAX carried on the distal end comprising a central region and end regions transitioning from the central region to attachment locations on the distal end, the balloon expandable from a contracted condition to an expanded condition; and   a supporting structure comprising a plurality of substantially inelastic fibers formed as a braid extending helically around an outer surface of the balloon and comprising opposite ends fixedly attached over the respective attachment locations such that intermediate regions the fibers are movable relative to the central region of the balloon, the fibers comprise polyethylene.   
     
     
         10 . The device of  claim 9 , wherein the fibers comprise a first set of fibers comprising polyethylene and a second set of fibers comprising polyamide. 
     
     
         11 . A method for making a balloon catheter, comprising:
 providing a balloon formed from non-compliant material comprising a central region and end regions on opposite ends of the central region, each end region including a relatively narrow neck;   positioning a plurality of inelastic fibers around the balloon such that the fibers extend helically around an outer surface of the balloon between the necks;   attaching opposite ends of the fibers over respective necks such that the fibers remain movable freely relative to the outer surface along at least the central region of the balloon; and   attaching the necks and attached fiber ends to the tubular member distal end at first and second spaced-apart attachment locations.   
     
     
         12 . The method of  claim 11 , further comprising braiding the fibers into a tubular mesh before positioning the fibers around the balloon. 
     
     
         13 . The method of  claim 12 , wherein the first and second sets of fibers are distributed substantially uniformly around a circumference of the mesh. 
     
     
         14 . The method of  claim 11 , wherein the fibers comprise a first set of fibers formed from polyethylene and a second set of fibers formed from polyamide. 
     
     
         15 . The method of  claim 14 , wherein the first set of fibers comprises polyethylene naphthalate (“PEN”) and the second set of fibers comprises Nylon 6. 
     
     
         16 . The method of  claim 14 , wherein the first set of fibers are formed entirely from polyethylene and the second set of fibers are formed entirely from polyamide. 
     
     
         17 . The method of  claim 14 , wherein attaching the opposite ends of the fibers comprises welding the opposite ends to the respective necks with the second set of fibers providing flux material to embed the opposite ends into the balloon material at the necks. 
     
     
         18 . The method of  claim 17 , wherein the ends of the second set of fibers are partially melted to embed the opposite ends of the fibers to the respective necks. 
     
     
         19 . The method of  claim 11 , wherein the opposite ends of the fibers are attached over the respective necks to provide a balloon-mesh assembly and wherein the ends of the balloon-mesh assembly are attached at precise locations on the tubular member. 
     
     
         20 . The method of  claim 19 , wherein the ends of the balloon-mesh assembly are attached to the precise locations on the tubular member by direct application of heat, e.g. through a split clamp. 
     
     
         21 . The method of  claim 11 , wherein the tubular member comprises a relatively short segment of a catheter, the method further comprising attaching one or more additional tubular members to the segment.